MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUARTET LEAD SMALL-S, 86 CM; PERMANENT PACEMAKER ELECTRODE

Model Number 1456Q/86

Device Problem Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented for an implant procedure.During the procedure, it was noted that the guidewire failed to advance in the left ventricular lead.The lead was not used and replaced.The patient was in a stable condition throughout the procedure.

Manufacturer Narrative

The reported event of failure to advance the guidewire was confirmed.As received, a complete lead was returned in one piece.A visual and x-ray examination found a damaged inner coil at the connector and distal region.The cause of the advancing guidewire issue was due to a damaged inner coil which was consistent with procedural damage.No other anomalies were seen.

• Brand Name: QUARTET LEAD SMALL-S, 86 CM
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16441720
• MDR Text Key: 310237147
• Report Number: 2017865-2023-10948
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734510158
• UDI-Public: 05414734510158
• Combination Product (y/n): Y
• Reporter Country Code: IN
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1456Q/86
• Device Catalogue Number: 1456Q/86
• Device Lot Number: A000129106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1